RecruitingNot Applicable

The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

Russia500 participantsStarted 2016-11-29

Plain-language summary

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;
. mitral valve disease requiring surgical disease

Exclusion criteria

. the need for prosthetics of two or more valves
. patients with a decrease in LVEF of less than 45%;
. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
. the diameter of the ascending aorta is more than 45 mm;
. unwillingness of the patient to participate in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

death

Timeframe: 10 years after surgery

prosthetic complications

Timeframe: 10 years after surgery

Trial details

NCT IDNCT04442100

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Elena B. Kim

ekim@cardio-tomsk.ru

View on ClinicalTrials.gov More Heart Valve Diseases trials